Operational Qualification Protocol for VHP Generator in Prefilled Syringes & Cartridges

Meta Description: This document outlines the Operational Qualification (OQ) protocol for the VHP Generator used in the production of prefilled syringes and cartridges, ensuring compliance with URS Annex11.

Tags: Equipment Validation, OQ, VHP Generator, Production

Objective

The objective of this protocol is to validate the operational performance of the VHP Generator in decontaminating the aseptic environment for the production of prefilled syringes and cartridges.

Scope

This protocol applies to the VHP Generator utilized in the production area for the decontamination of aseptic environments impacting the production of prefilled syringes and cartridges.

Responsibilities

• Validation Team: Responsible for executing the OQ protocol and documenting results.
• Quality Assurance: Responsible for reviewing and approving the protocol and results.
• Production Team: Responsible for providing operational support during validation activities.

Prerequisites

• Completion of Installation Qualification (IQ).
• Availability of all necessary documentation and equipment.
• Training of personnel on OQ procedures.

Equipment Description

The VHP Generator is a system designed to produce vaporized hydrogen peroxide for the decontamination of aseptic environments. It operates by dispersing vaporized hydrogen peroxide in controlled concentrations to achieve effective microbial reduction.

Test Plan

Detailed Test Cases

Test Case OQ-01: Verify Concentration Levels

Procedure: Monitor the concentration levels of vaporized hydrogen peroxide during the operational cycle using calibrated sensors.

Acceptance Criteria: Concentration must remain within the range defined in the URS Annex11.

Evidence: Documented concentration logs must be reviewed and verified.

Test Case OQ-02: Measure Dwell Time

Procedure: Record the dwell time for the decontamination cycle using the system’s audit trail functionality.

Acceptance Criteria: Dwell time must meet or exceed the specified duration outlined in the URS.

Evidence: Audit trail logs must be maintained and reviewed for compliance.

Deviations

Any deviations from the acceptance criteria must be documented in the deviation log, including the nature of the deviation, corrective actions taken, and impact assessment.

Approvals

This protocol must be approved by the Quality Assurance department prior to execution. All results must be reviewed and approved upon completion of the OQ activities.